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Through our experienced Design Centers of Excellence, we apply user-centered design from early research through validation. Our cross-functional teams—spanning design, engineering, and human factors—collaborate to define user needs, evaluate clinical environments, and refine products through research, task analysis, and iterative testing.
User & Use Environment Research
We conduct targeted research to understand how users interact with devices in clinical and home environments. By combining ethnographic methods, interviews, and contextual inquiry, we uncover key insights that shape usability strategy and support early-stage risk reduction.
- Research insights inform usability objectives and guide design requirements early in development.
- Early understanding of user context supports product acceptance and safe use.
- In-house observation rooms for impartial studies offer a streamlined service.
Device and Interface Design
We design and refine device interfaces, labeling, packaging, and instructions to support safe, intuitive use. This iterative, collaborative process incorporates feedback from users, engineers, and regulatory experts to ensure products are both user-friendly and compliant.
- User research and usability testing guide design solutions.
- Clear interfaces, labels, and instructions reduce user error and support confident, consistent use.
Use-Related Risk Management
We proactively address use-related risks throughout development to reduce the potential for user error and support device safety. Sanner applies tools such as use-related risk analysis (URRA), user failure modes and effects analysis (uFMEA), and ergonomic assessments to analyze device interaction in real-world clinical and home scenarios. These efforts support the development of intuitive designs, early identification of risk, and comprehensive documentation aligned with global regulatory requirements.
- Risk assessments inform design and usability strategy from early development onward.
- Ergonomic and anthropometric research supports comfortable, efficient use across user populations.
- Documentation supports FDA and international regulatory compliance.
Usability Testing
Sanner coordinates formative and summative usability studies throughout development at in-house US and UK facilities and partners with global sites when localized research or specific user groups are needed. These evaluations are designed to identify potential use issues early in development, confirm safe and effective use, and support regulatory readiness. Each study follows FDA guidance and IEC 62366 standards to support international submissions.
- Formative studies guide design iteration by uncovering use-related issues early.
- Summative testing confirms safe, effective use and supports regulatory approval.
- Representative user groups and real-world conditions improve reliability and relevance.
Human Factors Across the Development Process
Human factors considerations are integrated into every stage of development at Sanner. From initial planning through validation, our structured approach ensures usability risks are addressed early, design decisions are grounded in user insight and regulatory requirements are met with confidence.
We apply user insights in collaboration with design and engineering teams to refine interfaces, packaging, labeling, and instructions for use. Usability risks are addressed proactively, and design solutions are aligned with regulatory expectations. Ergonomic and anthropometric inputs are incorporated as needed to improve comfort and usability.
Formative studies are conducted with representative users in simulated-use settings in our observation suites or partner facilities. Methods may include heuristic reviews, cognitive walkthroughs, and user failure modes and effects analyses (uFMEA) to identify and address potential use-related issues. Additional evaluations, such as label comprehension testing and threshold analyses, may be included based on device needs.
Summative testing confirms that users can complete all critical tasks under expected conditions. These studies use representative user groups and generate documentation to support FDA and international regulatory submissions. Additional assessments, including workload analysis and comparative testing, may also be performed to ensure comprehensive validation.
Connect with Our Experts
Have questions about human factors and usability engineering? Sanner supports development programs from early-stage research through validation, drawing on deep expertise in usability research, risk analysis, and regulatory documentation. Whether refining an existing device or preparing for summative testing, our global team is ready to support the next step. Contact us today to learn more.